Recruitment

Recruitment Status
Completed
Estimated Enrollment
790

Inclusion Criterias

Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
...
Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation
Female subjects, age ≥ 18 years at the time informed consent is signed
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
At least 30 days from major surgery before randomization, with full recovery
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines
Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).
Hemoglobin (Hgb) ≥ 9 g/dL
Able to adhere to the study visit schedule and other protocol requirements
Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and
Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis
No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.
Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines
Platelets ≥ 100,000/mm^2 ;
Creatinine clearance > 60 mL/min (by Cockcroft-Gault)
Absolute Neutrophil Count (ANC) ≥ 1500/mm^2 ;
Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
Life expectancy ≥ 16 weeks from randomization
Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x upper limit of normal range (ULN); if hepatic metastases present ≤ 5.0 x ULN
Pathologically confirmed adenocarcinoma of the breast

Summary

Conditions
  • Breast Cancer
  • Breast Tumor
  • Cancer of the Breast
  • Estrogen Receptor- Negative Breast Cancer
  • HER2- Negative Breast Cancer
  • Metastatic Breast Cancer
  • Progesterone Receptor- Negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Triple-negative Breast Cancer
  • Triple-negative Metastatic Breast Cancer
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Recep...

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer. Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.

Inclusion Criterias

Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
...
Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines
Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation
Female subjects, age ≥ 18 years at the time informed consent is signed
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
At least 30 days from major surgery before randomization, with full recovery
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines
Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).
Hemoglobin (Hgb) ≥ 9 g/dL
Able to adhere to the study visit schedule and other protocol requirements
Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and
Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis
No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.
Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines
Platelets ≥ 100,000/mm^2 ;
Creatinine clearance > 60 mL/min (by Cockcroft-Gault)
Absolute Neutrophil Count (ANC) ≥ 1500/mm^2 ;
Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)
Life expectancy ≥ 16 weeks from randomization
Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x upper limit of normal range (ULN); if hepatic metastases present ≤ 5.0 x ULN
Pathologically confirmed adenocarcinoma of the breast

Locations

Ottawa, Ontario, K1H 8L6
Jau/SP, São Paulo, 17210-080
La Verne, California, 91750
Richmond, Virginia, 23230
Rio De Janerio, Rio De Janeiro, 20560-120
...
Ottawa, Ontario, K1H 8L6
Jau/SP, São Paulo, 17210-080
La Verne, California, 91750
Richmond, Virginia, 23230
Rio De Janerio, Rio De Janeiro, 20560-120
Joliet, Illinois, 60435
San Sebastian, 20014
Ribeirao Preto, 14048-900
Salvador, Bahia, 41820-021
San Luis Obispo, California, 93401
Athens, 11528
Detroit, Michigan, 48202-268
Napoli, Campania, 80131
São Paulo, 03102-002
Roma, 144
Lafayette, Louisiana, 70503
Santa Maria, California, 93454
Regina, Saskatchewan, S4T1A5
Anaheim, California, 92801
Nashville, Tennessee, 37203
Sheffield South Yorkshire, S10 2SJ
Barcelona, 8035
Garran, Australian Capital Territory, 2605
Nedlands, 6009
Innsbruck, 6020
Madrid, 28007
Messina, 98158
Rio Patras, 26500
Columbus, Ohio, 43219
New York, New York, 10021
Hildesheim, 31134
Coos Bay, Oregon, 97420
Heraklion, 71110
Chattanooga, Tennessee, 37404
Porto Alegre, Rio Grande Do Sul, 90035-001
Rio Grande Do Sul, 95900-000
Jacksonville, Florida, 32224
Englewood, New Jersey, 07631
Rozzano (MI), 20089
Bonn, 53111
Langhorne, Pennsylvania, 19047
Burlington, North Carolina, 27215-8700
Boca Raton, Florida, 33486
Torino, Piemonte, 10126
Köln, 50679
Grosseto, 58100
Treviglio, 24047
Miami, Florida, 33136
München, 81377
Frankston, Victoria, 3199
Green Bay, Wisconsin, 54301
Ulm, 89075
La Jolla, California, 92093
Faliro, 18547
Los Angeles, California, 90045
Fort Worth, Texas, 76104
Barretos, São Paulo, 14784-400
Kansas City, Missouri, 64132
Portland, Oregon, 97213
Quebec City, Quebec, G1S4L8
Hollywood, Florida, 33021
Dallas, Texas, 75246
Minneapolis, Minnesota, 55407
Vienna, 1090
Tyler, Texas, 75702
Urbana, Illinois, 61801
Porto, 4200-072
Genova, 16132
Sao Jose Do Rio Preto, 15090-000
Heidelberg, 69120
Lisboa, 1649-035
Sarasota, Florida, 34232
Roma, 00189
Escondido, California, 92025
San Antonio, Texas, 78217
Cincinnati, Ohio, 45219
Chandler, Arizona, 85224
Lebanon, New Hampshire, 03756
Wodonga, Victoria, 3690
Cincinnati, Ohio, 45242
Huntington, West Virginia, 25701
Manchester, M20 4BX
Saint Louis, Missouri, 63131
Frankfurt, 60431
London, W1G 6AD
Fredericksburg, Virginia, 22408
Porto Alegre, Rio Grande Do Sul, 90610-000
Toledo, Ohio, 43623
Sevilla, 41071
Curitiba, Paraná, 81520-060
Baltimore, Maryland, 21201
Milwaukee, Wisconsin, 53211
Bologna, Emilia-Romagna, 40138
West Palm Beach, Florida, 33401
Roma, 00168
Lisboa, 1500-650
Portland, Oregon, 97213
East Syracuse, New York, 13057
Salzburg, 5020
Freiburg, 79110
Fayetteville, Arkansas, 72703
Athens, 15562
Middlesex, HA62RN
Saint Petersburg, Florida, 33705
Spokane, Washington, 99208
Clermont-Ferrand, 63003
Glendale, Arizona, 85306
Pittsburgh, Pennsylvania, 15213
Portsmouth, Virginia, 23704
Cordoba, 14004
Napoli, Campania, 80131
Sao Paulo, 05651-901
Dallas, Texas, 75231
Zaragoza, 50009
Trier, 54290
Padova, 35128
Barcelona, 08036
Rimouski, Quebec, G5L5T1
Indianapolis, Indiana, 46254
Berlin, 10713
Scottsdale, Arizona, 85259
Santa Rosa, California, 95403
Reggio Emilia, 42100
Fortaleza, 60160-230
Ferrara, 44124
Montreal, Quebec, H2L 4M1
Rochester, Minnesota, 55905
Bath, BA1 3NG
São Paulo, 01308-050
Lawton, Oklahoma, 73505
Hooksett, New Hampshire, 03106
Santiago de Compostela, 15706
Houston, Texas, 77030
Ribeirao Preto, 14015-130
Evora, 7000-811
Monza, 20900
Columbia, South Carolina, 29210
Lake Success, New York, 11042
Scottsdale, Arizona, 85251
Bethesda, Maryland, 20817

Tracking Information

NCT #
NCT01881230
Collaborators
Not Provided
Investigators
Study Director: Ileana Elias, M.D. Celgene Corporation